Human Research Subject Protection in Thailand: Issues of Applicable Laws and Regulations - การปกป้องคุ้มครองอาสาสมัครในการวิจัยในประเทศไทย: ประเด็นปัญหาของกฎหมาย และข้อบังคับทีเกี่ยวข้อง

บทคัดย่อ

               Human subject research is a necessary step in the advancement of treatment and prevention of diseases. According to ethical principles and international human research standards, there must be regulations governing human subject research to protect human rights and integrity, as well as the safety and well-being of the subjects. Thailand currently does not have specific laws pertaining to human subject research, resulting in the need to improvise from various laws as well as rules and regulations by health related councils. To date, there has not been any review or analysis of pertinent laws, rules, and regulations to ascertain whether they provide the same protections for human subjects in research as those required by ethical and international standards. This article reviews, analyzes and discusses relevant Thai laws and regulations concerning human subject research focusing on the two mechanisms for human research subject protection i.e. the review of research by ethic committee and the process of informed consent. There are several weaknesses in the laws, rules and regulations currently in place which call into question their ability to fully protect human subjects in research. Amendments and additions should be made to the current laws and regulations so that their enforcement will adhere more strictly to ethical and international human research standards.

Key words: clinical research, ethics, human experiemntation, Thailand, ligislation and jurisprudence